Genzyme’s MS drug receives EU positive recommendation

A committee of the European Medicines Agency has issued Sanofi's subsidiary Genzyme with a positive recommendation for approval of Lemtrada (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

The Committee for Medicinal Products for Human Use (CHMP) based its recommendation on data from two clinical trials, in which Lemtrada was found to be significantly more effective than Rebif (subcutaneous interferon beta-1a 44 mcg three times weekly) at reducing relapse rates.

In one of the trials, called CARE-MS II, accumulation of disability was significantly slowed in patients given Lemtrada vs. Rebif, and importantly, patients treated with Lemtrada were significantly more likely to experience improvement in pre-existing disability.

"Today's CHMP opinions set the stage for the approval of two important new treatment options for [multiple sclerosis] MS patients. Treatments to-date have addressed some of the unmet needs in MS, but still have limitations. Upon approval, physicians will have the ability to prescribe LEMTRADA for appropriate relapsing remitting patients based on their impressions of clinical or imaging characteristics regardless of duration of disease or treatment history. Expectations among the MS community are high for LEMTRADA and with today's positive CHMP opinion we are a step closer to making this very innovative treatment available for MS patients in Europe."

David Meeker, MD, Genzyme President and CEO.

In addition, the CHMP issued a positive opinion on new active substance designation (NAS) for Aubagio (teriflunomide). The Committee recommended the approval of Aubagio for the treatment of adult patients with RRMS earlier on this year.

The European Commission (EC) is expected to render a final decision to grant marketing authorizations for both of Genzyme's MS drugs in the EU in the coming months.

Meanwhile, Sanofi has announced it has received approval for its type 2 diabetes drug from the Japanese government. Lyxumia (lixisenatide) has been approved for the treatment of type 2 diabetes in combination with basal insulin and is part of a new class of diabetes drugs called GLP-1 analogues. This drug is also approved in the European Union, Mexico and Australia and is currently being reviewed in the United States.